Sejaro® (tirzepatide)

1. What is Sejaro® and what it is used for

Sejaro® contains tirzepatide as an active substance and is used to treat adults with type 2 diabetes mellitus. Tirzepatide has an effect on glucagon-like peptide-1 receptors (GLP-1 receptors) and glucose-dependent insulinotropic polypeptide receptors (GIP-R) by increasing insulin secretion and body sensitivity to insulin only when the blood sugar level is high.

Sejaro® is also used to treat adults with obesity (body mass index (BMI): NLT 30 kg/m²) or adults with overweight (BMI: NLT 27 kg/m²), having such concomitant conditions as pre-diabetes or type 2 diabetes mellitus, high blood pressure, abnormal blood fat level, trouble breathing during sleep (called as obstructive sleep apnoea) or cardiovascular diseases.

Sejaro® is indicated as a supplement to a low-calorie diet and physical exercise.

Therapeutic indications

Sejaro® is indicated for the treatment of adults over 18 years of age with type 2 diabetes mellitus (T2DM) in addition to a low-calorie diet and physical exercise to improve glycaemic control, and it is used:

• alone when metformin is not a choice;
• in combination therapy with other antidiabetic agents.

Sejaro® is indicated for use in adults over 18 years of age in addition to a low-calorie diet and physical exercise to control body weight, including weight loss and maintenance in adults with baseline body mass index (BMI) equal to:

• ≥ 30 kg/m² (obesity), or
• ≥ 27 kg/m² and < 30 kg/m² (overweight) and having at least one weight-associated comorbidity, e. g., dysglycaemia (pre-diabetes or type 2 diabetes mellitus), arterial hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.

Mechanism of action of Sejaro®

Sejaro® has an effect on the receptors by increasing insulin secretion and body sensitivity to insulin only when the blood sugar level is high. In addition, Sejaro® has an effect on the brain receptors that control your appetite, making you feel satiated, as well as experiencing fewer food cravings. This will help you eat less food and reduce your body weight.

If there is no improvement or if you feel worse, please consult your physician.

INSTRUCTION FOR MEDICAL USE OF MEDICINAL PRODUCT SEJARO®

Trade name: Sejaro®

International non-proprietary name (INN): Tirzepatide

Dosage form: solution for subcutaneous injection

Composition

Pharmacotherapeutic group of the medicinal product: antidiabetic drugs; hypoglycaemic agents other than insulins; other hypoglycaemic agents other than insulins.

АТC code: A10BX16

1. What is Sejaro® and what it is used for

Sejaro® contains tirzepatide as an active substance and is used to treat adults with type 2 diabetes mellitus. Tirzepatide has an effect on glucagon-like peptide-1 receptors (GLP-1 receptors) and glucose-dependent insulinotropic polypeptide receptors (GIP-R) by increasing insulin secretion and body sensitivity to insulin only when the blood sugar level is high.

Sejaro® is also used to treat adults with obesity (body mass index (BMI): NLT 30 kg/m²) or adults with overweight (BMI: NLT 27 kg/m²), having such concomitant conditions as pre-diabetes or type 2 diabetes mellitus, high blood pressure, abnormal blood fat level, trouble breathing during sleep (called as obstructive sleep apnoea) or cardiovascular diseases.

Sejaro® is indicated as a supplement to a low-calorie diet and physical exercise.

Therapeutic indications

Sejaro® is indicated for the treatment of adults over 18 years of age with type 2 diabetes mellitus (T2DM) in addition to a low-calorie diet and physical exercise to improve glycaemic control, and it is used:

• alone when metformin is not a choice;
• in combination therapy with other antidiabetic agents.

Sejaro® is indicated for use in adults over 18 years of age in addition to a low-calorie diet and physical exercise to control body weight, including weight loss and maintenance in adults with baseline body mass index (BMI) equal to:

• ≥ 30 kg/m² (obesity), or
• ≥ 27 kg/m² and < 30 kg/m² (overweight) and having at least one weight-associated comorbidity, e. g., dysglycaemia (pre-diabetes or type 2 diabetes mellitus), arterial hypertension, dyslipidaemia, obstructive sleep apnoea, or cardiovascular disease.

Mechanism of action of Sejaro®

Sejaro® has an effect on the receptors by increasing insulin secretion and body sensitivity to insulin only when the blood sugar level is high. In addition, Sejaro® has an effect on the brain receptors that control your appetite, making you feel satiated, as well as experiencing fewer food cravings. This will help you eat less food and reduce your body weight.

If there is no improvement or if you feel worse, please consult your physician.

2. What you should know before using Sejaro®

Contraindications

Do not use Sejaro®, if you have:

• Hypersensitivity to tirzepatide or any of the excipients in the medicinal product listed in Section 6;
• If you are pregnant or breastfeeding.

Special warnings and precautions

Please consult your physician before using Sejaro®.

Sejaro® should be used with caution in the following patient populations due to the lack of data on the efficacy and safety or limited experience:

• If you have a history of pancreatitis (inflammation of the pancreas);
• If you have severe renal impairment or hepatic impairment;
• If you have severe gastrointestinal diseases or food remains in your stomach longer than usual (including severe gastroparesis).

Be sure to tell your physician if any of the following applies to you:

• If you experience severe and persistent abdominal pain, heartburn, nausea, vomiting or worsening of general condition, please seek medical attention as this may be a sign of acute pancreatitis (inflammation of the pancreas).
• If you take sulphonylurea or insulin derivatives. Sejaro® in combination with these medicinal products may increase the risk of lower blood sugar levels (hypoglycaemia). Please consult your physician as you may need a lower dose of sulphonylurea or insulin products.
• If you developed any gastrointestinal disorders. While being treated with Sejaro®, you may have such gastrointestinal (GI) adverse reactions as nausea, vomiting or diarrhoea which can cause dehydration (fluid loss) resulting in a deterioration of renal function in rare cases. It is important that you drink enough fluids to avoid dehydration.
• If you have diabetic retinopathy (diabetic eye disease) or eyesight disorders (macular oedema). Fast improvement in blood sugar control can lead to a temporary exacerbation of diabetic eye disease. If you have vision problems, please consult your physician.
• If you have any scheduled surgeries under general anaesthesia or deep sedation. Due to delayed gastric emptying and the presence of residual gastric contents in the stomach when using GLP-1 agonists, there is a risk of aspiration or aspiration pneumonia during anaesthesia or sedation.

Please consult your physician if you still have any questions.

Children and adolescents

Do not use Sejaro® in children aged 0 to 18 years as its safety and efficacy have not been established. No data available.

Other medicinal products and Sejaro®

Please tell your physician if you are taking, have recently taken, or may start taking any other medicinal products.

Please tell your physician if you are taking warfarin-containing medicinal products or other medicines to reduce coagulation (oral anticoagulants), or digoxin (cardiac glycoside) or other similar agents.

Pregnancy and lactation

Do not use Sejaro®, if you are pregnant, think you may be pregnant or are planning pregnancy, because it is not known whether it can affect the development of your unborn baby.

Use effective contraceptives while taking Sejaro®.

Do not use Sejaro® if you are breast-feeding, as it is not known whether this medicinal product penetrates into human breast milk.

Driving and operating machinery

Sejaro® will not affect your ability to drive and use machinery. However, Sejaro® in combination with sulphonylurea derivatives or insulin can reduce blood sugar levels (hypoglycaemia) and impair the patient’s ability to concentrate (see Special warnings and precautions for information on the increased risk of low blood sugar levels and Section 4 for warning signs of low blood sugar levels). If you feel dizziness, headache, drowsiness, weakness, hunger, confused consciousness, irritability, rapid heartbeat and sweating, do not drive a vehicle or operate machinery until you feel better.

If you need more information, please contact your physician.

Excipients

Sejaro® contains sodium of less than 1 mmol (23 mg) per dose (2.4 mg), i. e. it is essentially “sodium-free”.

Sejaro® contains 5.4 mg of benzyl alcohol per 0.6 mL dose (9 mg in each mL). Benzyl alcohol is contraindicated in premature infants and neonates. It can cause toxic and anaphylactoid reactions in infants and children under 3 years of age.

3. How to use Sejaro®

Always strictly follow your physician’s recommendations when using the medicinal product. If in doubt, please consult your physician.

Your physician will determine the dose and mode of administration of the medicinal product based on your individual characteristics.

Recommended dose

Adults

The recommended starting dose is 2.5 mg once weekly for 4 weeks. In 4 weeks, your physician will increase the dose of the medicinal product to 5 mg once weekly. If necessary, your physician can increase the dose by 2.5 mg up to 7.5 mg, 10 mg, 12.5 mg, or 15 mg once weekly. In each case, your physician will tell you to take the prescribed dose for at least 4 weeks before switching to a higher dose.

Do not change the dose until your physician recommends it!

Route and mode of injection

Sejaro® is administered subcutaneously (subcutaneous injection) using a pen injector.

Never inject Sejaro® intravenously or intramuscularly.

You can inject yourself at any time of the day, regardless of meals.

The best injection sites are the abdominal area at least 5 cm from the navel or the upper leg (thigh) or shoulder.

You can use the same area of your body each week, but be sure to choose a different injection site in that area. If you are also injecting insulin, choose a different area for that injection.

Inject Sejaro® once a week, on the same day of the week. If necessary, you can change the day of your weekly injection if not less than 3 days have passed since your last injection. After selecting a new injection day, continue to use this medicinal product once a week.

Before you use the pen injector for the first time, please ask your physician to show you how to use it. Please carefully read the user’s manual of the Sejaro® pre-filled pen injector enclosed in the package. When using the pen injector, please carefully follow the user’s manual.

Always make sure you are taking the correct strength of Sejaro®.

If you use Sejaro® in combination with sulphonylurea or insulin, it is important to monitor your blood glucose levels as advised by your physician to prevent low blood sugar levels (hypoglycaemia) (see Section 2 Special warnings and precautions).

Treatment duration

Your physician will regularly monitor your condition and tell you how long you should use Sejaro®.

If you used more Sejaro® than you should

Please consult your physician immediately. You may have such gastrointestinal (GI) adverse reactions as nausea. If you use Sejaro® in combination with sulphonylurea or insulin, you may have an increased risk of low blood sugar levels (hypoglycaemia).

You may need symptomatic therapy.

If you forget to inject Sejaro®

If you forget to inject a dose and:

• If 4 days or less have passed since you should have injected Sejaro®, inject the missed dose as soon as you remember. Then inject your next dose as usual on your scheduled day.
• If more than 5 days have passed since you should have injected Sejaro®, do not inject the missed dose. Then wait and inject your next dose as usual on your scheduled day.

Never take a double dose to make up for a missed dose.

The Sejaro® dosing interval should be not less than 3 days.

If you stop taking Sejaro®

Do not stop using Sejaro® without consulting your physician.

If you have type 2 diabetes mellitus (T2DM) or have used Sejaro®, your blood sugar may increase after you stop using Sejaro®.

If you have any additional questions about the medicinal product Sejaro®, consult your physician.

4. Possible adverse reactions

Like all medications, Sejaro® may cause adverse reactions; however, not all people experience them.

Most serious adverse reactions

Stop taking Sejaro® and immediately seek medical attention if you have one of the following signs of severe allergic reaction (anaphylactic reactions, angioedema), which were rare (may occur in ≤ 1 in 1000 people):

• breathing or swallowing difficulties;
• dizziness;
• face, lip, tongue, or throat oedema;
• severe skin itching, rash or blisters;
• feeling near fainting (fall in blood pressure) with rapid heartbeat and sweating;
• cold and pale skin, dizziness or weakness.

Please seek medical attention immediately if you experience symptoms of inflamed pancreas (acute pancreatitis) which was observed uncommonly (may occur in ≤ 1 of 100 people):

• severe and long-lasting abdominal pain which can radiate to the back;
• sudden intense pain in the entire abdominal area;
• heartburn;
• bouts of vomiting;
• abdominal distention and flatulence;
• worsening of general condition: fever, low blood pressure, tachycardia, sweating, pale or yellowish skin.

If you have type 2 diabetes mellitus, please tell your physician, if, when taking Sejaro®, you experience any vision problems, e. g. visual impairment that is a common adverse reaction (may occur in ≤ 1 in 10 people):

• Complications of diabetic eye disease (diabetic retinopathy).

Other potential adverse reactions that may be observed during treatment with Sejaro®

Very common (may occur in ≥ 1 of 10 people):

• Decreased blood sugar levels (hypoglycaemia*) in T2DM patients when used in combination with insulin or sulphonylurea products;
• Nausea;
• Diarrhoea.

Common (may occur in ≤ 1 of 10 people):

• Dizziness;
• Reduced blood pressure (hypotension);
• Decreased blood sugar levels (hypoglycaemia*) in T2DM patients when used in combination with metformin or SGLT2 inhibitors;
• Decreased appetite;
• Abdominal pain;
• Vomiting;
• Dyspepsia;
• Constipation;
• Abdominal distention;
• Eructation;
• Flatulence;
• Reflux or heartburn, also called gastroesophageal reflux disease;
• Hair loss;
• Feeling of faintness or fatigue;
• Injection site reactions;
• Fast heartbeat;
• Increased lipase and amylase levels in complete blood count.

Uncommon (may occur in ≤ 1 in 100 people):

• Decreased blood sugar levels (hypoglycaemia*) in T2DM patients when used in combination with metformin;
• Body weight decreased;
• Gallstone disease (cholelithiasis);
• Gallbladder inflammation (cholecystitis);
• Administration site pain;
• Increased calcitonin levels.

*Signs of low blood sugar may appear suddenly. They may include: cold sweat, cool pale skin, headache, fast heartbeat, feeling sick (nausea) or feeling very hungry, changes in vision, feeling sleepy or weak, feeling nervous, anxious or confused, difficulty concentrating, or shaking. Your physician will tell you how to increase your blood sugar level and what to do if you notice these warning signs. Hypoglycaemia is more likely to occur if you take sulphonylurea derivatives or insulin. Your physician may reduce the doses of these medications before you start treatment with Sejaro®.

Please tell your physician if you have any new symptoms or if your existing symptoms worsen.

Reporting adverse reactions

If you experience any adverse reactions, please consult your physician, a pharmacist or a nurse. This recommendation covers all possible adverse reactions, including those not listed in this Patient Information Leaflet. You may also report adverse reactions directly via the reporting system of the member states of the Eurasian Economic Union. Your reports of adverse reactions help us gather more information on medicinal product safety.

Russian Federation
Federal Service for Surveillance in Healthcare (Roszdravnadzor)
Address: 4/1, Slavyanskaya ploshchad, 109012, Moscow
Tel.: +7 800 550 99 03
E-mail: pharm@roszdravnadzor.gov.ru
Website: www.roszdravnadzor.gov.ru

5. How to store Sejaro®

Keep Sejaro® out of reach and sight of children.

Do not use Sejaro® after the expiry date (shelf life) which is stated on the label of the pen injector and the carton. The expiry date is the last day of this month.

Store Sejaro® in a refrigerator at 2 °C to 8 °C.

Do not freeze, do not place near a freezer, do not use if the medicinal product has been frozen.

After first use

Keep the pen injector with Sejaro® that is in use or carried as a spare one at a temperature below 30 °C for not more than 30 days.

Do not use Sejaro® if the pen injector is damaged or if the solution is turbid, changes its colour or has particles in it.

Do not discard the product (do not pour it out) into the sewage system. Please ask a pharmacist how to dispose of (destroy) the medicinal product you no longer need. These measures help protect the environment.

6. Package contents and other information

Sejaro® contains

The active ingredient is tirzepatide.

Sejaro®, 2.5 mg/dose, solution for subcutaneous injection
Each mL of the solution contains 4.17 mg of tirzepatide. Each pre-filled pen injector contains 10 mg of tirzepatide per 2.4 mL of the solution.

Other components (excipients): sodium hydrogen phosphate heptahydrate, benzyl alcohol, glycerol, phenol crystalline, sodium chloride, 10 % diluted hydrochloric acid and/or 10 % sodium hydroxide solution (for pH adjustment), water for injection.

Sejaro®, 5 mg/dose, solution for subcutaneous injection
Each mL of the solution contains 8.33 mg of tirzepatide. Each pre-filled pen injector contains 20 mg of tirzepatide per 2.4 mL of the solution.

Other components (excipients): sodium hydrogen phosphate heptahydrate, benzyl alcohol, glycerol, phenol crystalline, sodium chloride, 10 % diluted hydrochloric acid and/or 10 % sodium hydroxide solution (for pH adjustment), water for injection.

Sejaro®, 7.5 mg/dose, solution for subcutaneous injection
Each mL of the solution contains 12.5 mg of tirzepatide. Each pre-filled pen injector contains 30 mg of tirzepatide per 2.4 mL of the solution.

Other components (excipients): sodium hydrogen phosphate heptahydrate, benzyl alcohol, glycerol, phenol crystalline, sodium chloride, 10 % diluted hydrochloric acid and/or 10 % sodium hydroxide solution (for pH adjustment), water for injection.

Sejaro®, 10 mg/dose, solution for subcutaneous injection
Each mL of the solution contains 16.67 mg of tirzepatide. Each pre-filled pen injector contains 40 mg of tirzepatide per 2.4 mL of the solution.

Other components (excipients): sodium hydrogen phosphate heptahydrate, benzyl alcohol, glycerol, phenol crystalline, sodium chloride, 10 % diluted hydrochloric acid and/or 10 % sodium hydroxide solution (for pH adjustment), water for injection.

Sejaro®, 12.5 mg/dose, solution for subcutaneous injection
Each mL of the solution contains 20.83 mg of tirzepatide. Each pre-filled pen injector contains 50 mg of tirzepatide per 2.4 mL of the solution.

Other components (excipients): sodium hydrogen phosphate heptahydrate, benzyl alcohol, glycerol, phenol crystalline, sodium chloride, 10 % diluted hydrochloric acid and/or 10 % sodium hydroxide solution (for pH adjustment), water for injection.

Sejaro®, 15 mg/dose, solution for subcutaneous injection
Each mL of the solution contains 25 mg of tirzepatide. Each pre-filled pen injector contains 60 mg of tirzepatide per 2.4 mL of the solution.

Other components (excipients): sodium hydrogen phosphate heptahydrate, benzyl alcohol, glycerol, phenol crystalline, sodium chloride, 10 % diluted hydrochloric acid and/or 10 % sodium hydroxide solution (for pH adjustment), water for injection.

Sejaro® contains sodium, benzyl alcohol (see Section 2).

Sejaro® appearance and package contents

Sejaro®, solution for subcutaneous injection, is a colourless or slightly yellowish clear solution.

2.4 mL in clear neutral glass cartridges (hydrolytic grade I) with rubber plungers sealed with flip-off aluminium caps with rubber discs.

Each cartridge is pre-installed in a plastic multidose disposable pen injector for multiple injections to inject only one dose of the following doses: 2.5/ 5/ 7.5/ 10/ 12.5/ 15 mg/dose. A label made of polypropylene film is applied to the body of each pen injector.

1 pre-filled multidose disposable pen injector for multiple injections and 1 cardboard package containing 4 disposable needles, the Patient Information Leaflet and the user’s manual for a pen injector are placed into a carton.

Marketing authorisation holder

Russian Federation
ООО “GEROPHARM”,
9, ul. Zvenigorodskaya, Saint Petersburg, 191119
Tel.: +7 (812) 703 79 75 (multi-line)
Fax: +7 (812) 703 79 76
E-mail: inform@geropharm.ru

Manufacturer

Russian Federation
ООО “GEROPHARM”
1. Bldg. 5, Kvartal A area, Obolensk settlement, Serpukhov city district, Moscow region
2. Unit 1, bldg. 5, Kvartal A area, Obolensk settlement, Serpukhov city district, Moscow region
3. Unit 82, bldg. 4, Kvartal A area, Obolensk settlement, Serpukhov city district, Moscow region

All consumer complaints should be sent to the marketing authorisation holder or its representative:

Russian Federation
ООО “GEROPHARM”, 4, bldg. 1, Yachevsky proezd, Pushkin, Saint Petersburg, 196608
Tel.: +7 (812) 703 79 75
Fax: +7 (812) 703 79 76
E-mail: inform@geropharm.ru; farmakonadzor@geropharm.com

Other references

Detailed information about this medicinal product is available at the EAEU website: https://eec.eaeunion.org/

The pen injector is a pre-filled disposable pen injector for multiple injections (“pen injector”) with tirzepatide, an antidiabetic drug, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) analogue.

Sejaro® (2.5 mg/dose; 5 mg/dose; 7.5 mg/dose; 10 mg/dose; 12.5 mg/dose; 15 mg/dose) is a solution for subcutaneous injection in a pre-filled pen injector. One pen injector contains no less than 2.4 mL of the solution.

Only one of the following doses can be selected on each Sejaro® pen injector: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg.

One pre-filled pen injector of each dosage contains 4 doses of Sejaro®:

• 2.5 mg/dose: 2.5 mg/0.6 mL, 10 mg of tirzepatide in 2.4 mL of the solution
• 5 mg/dose: 5 mg/0.6 mL, 20 mg of tirzepatide in 2.4 mL of the solution
• 7.5 mg/dose: 7.5 mg/0.6 mL, 30 mg of tirzepatide in 2.4 mL of the solution
• 10 mg/dose: 10 mg/0.6 mL, 40 mg of tirzepatide in 2.4 mL of the solution
• 12.5 mg/dose: 12.5 mg/0.6 mL, 50 mg of tirzepatide in 2.4 mL of the solution
• 15 mg/dose: 15 mg/0.6 mL, 60 mg of tirzepatide in 2.4 mL of the solution

The pen injector is to be used with disposable injection needles manufactured by WellFine, Dexfine or Verifine. Each Sejaro® package includes 4x WellFine 4 mm 32G (Dexfine 4 mm 32G or Verifine 4 mm 32G) needles.

Inject Sejaro® only with the needles up to 8 mm long.

Make sure to attach a new needle before each injection. After an injection, store and carry the pen injector without a needle! It helps prevent needle blocking and contamination, infection, solution leakage, and injection of a wrong dose.

Needles must be disposed in accordance with local requirements, rules and regulations for handling potentially infectious materials.

One pen injector may be used only by one person at a time. Make sure to never share your pen injector with anyone.

If Sejaro® in the pen injector looks not like a colourless clear solution, then do not use it.

Do not expose the pen injectors to low or high temperatures (below + 2 °C or above + 30 °C). Do not put pen injectors in a freezer. Pen injectors must not be frozen!

Used pen injectors must be disposed and not be reused (do not try to refill them).

Make sure to carry the pen injector in a special thermal case/bag (such as the original GEROPHARM case) when the temperature is too high or low.

Keep the pen injector and its needles out of reach of everyone, especially children.

Do not try fixing the pen injector by yourself. If the pen injector is broken, please contact the organisation that accepts consumer claims as indicated in the instruction for medical use. GEROPHARM helpline: 8 (800) 333-43-76.

User’s manual for pre-filled pen injector containing Sejaro®, 2.5 mg/dose, 5 mg/dose, 7.5 mg/dose, 10 mg/dose, 12.5 mg/dose, 15 mg/dose, solution for subcutaneous injection.

Before the first injection, please read carefully the user’s manual for pre-filled disposable pen injectors.

Please also consult your doctor (specialist) on how to use the pen injector. Please ask them to demonstrate the proper use of the pen injector. The first injection of the medicinal product must be carried out under the supervision of a doctor or nurse.

Please read the label of the pen injector carefully to make sure that you use the medicinal product and the dosage that your doctor prescribed to you and to check whether the medicinal product is not expired. Then look at the pictures below to get familiar with the characteristics and components of the pen injector.

Before getting started with the pen injector, check it carefully for visible mechanical damage or leakage (this may happen when the cartridge is not properly sealed). Never use the pen injector if you are not sure that it is functioning and is not damaged. Always check your pen injector before each injection.

Follow the instruction for use of the pen injector carefully: do not drop it and make sure to protect it from environmental factors (heat, direct sunlight, damage, physical damage, etc.). If the pen injector is damaged, replace it with another one immediately.

Visually impaired patients or patients with severe vision issues who cannot see the numbers on the dose counter must use the pen injector only under the supervision of medical personnel, relatives or any person with good vision who has been trained to inject medicinal products using pre-filled pen injectors.

Caregivers must handle used needles with extreme caution to prevent accidental injections and cross-infections.

Sejaro® pre-filled pen injector

1. Check the name on the pen injector label

Make sure that the pen injector contains Sejaro® (2.5; 5; 7.5; 10; 12.5; 15 mg/dose). This is especially important if you are using several injectable medicinal products.

1. Prepare your pen with a new needle

When the needle is being placed on the cartridge holder, a drop of the medicinal product may appear, which is acceptable, but you still need to check how the medicinal product flow through the needle if the pen injector is used for the first time. Attach a new needle to the pen injector immediately before the injection, when the patient is ready.

2. Check how the medicinal product flows through the needle

If no drop appears at the needle tip after the medicinal product starts passing through, then repeat the steps listed in Paragraph II, but not more than 6 times. If no drop still appears, then replace the needle and repeat the steps listed in Paragraph II to check the medicinal product flow again. If a drop of the solution does not appear, then dispose the pen injector and use a new one.

Before using the pen injector for the first time, make sure that the medicinal product smoothly passes through the needle and a drop of solution appears at the needle tip. This will ensure proper injection of the medicinal product. If the needle is damaged or blocked, then no drop of solution will appear and the medicinal product will not be injected, even if the dose selector and dose counter are moving. In this case, the patient will not get the prescribed dose and the intended effect of Sejaro® will not be achieved. Make sure to check that the medicinal product smoothly passes through the needle before the first injection.

3. Dose setting

Before each injection, make sure to check the medicinal product dose (in mg) set by the patient using the dose counter and dose indicator readings. Do not count the clicks of the pen injector. Only one of the following Sejaro® doses can be selected on the pen injector: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg.

The choice can be made using the dose selector. When the dose is set correctly, the dose pointer in the dose window will show “-1” corresponding to 1 dose of Sejaro® (2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg). If the pen injector contains less than 2.5; 5; 7.5; 10; 12.5 or 15 mg, then the dose counter will stop before “1” appears.

Important! Do not use the pen injector when there is not enough medicinal product left to inject the full dose. Use a new pen injector instead.

4. Needle disposal

Important! Always remove the needle from the pen injector after each injection. It helps prevent needle blocking and contamination, infection, solution leakage, and injection of a wrong dose. Store and carry the pen injector without a needle!

5. Pen injector care

Treat your pen injector with care. Rough handling or misuse may cause inaccurate dosing of Sejaro®, which may lead to very high or low blood glucose concentrations or abdominal discomfort (nausea, vomiting, diarrhoea).

Do not expose your pen injector to dust, dirt or liquid. Do not wash or soak your pen injector. Clean your pen injector with a mild detergent on a moistened cloth when necessary.

If the pen injector has been subjected to physical impact (shock, mechanical vibration, thermal phenomena, etc.) or seems to be non-functioning, make sure to attach a new needle and check how the medicinal product passes through it before injecting.

It is prohibited to leave the pen injector in places where it can be exposed to very high or low temperatures (in a car, close to windows, etc.). Do not inject Sejaro® which has been frozen.

Used (empty) pen injectors must be disposed. Dispose empty pen injectors with detached needles in accordance with local regulations or the recommendations given by your physician, nurse or pharmacist.

The pen injector is a pre-filled disposable pen injector for multiple injections (“pen injector”) with tirzepatide, an antidiabetic drug, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) analogue.

Sejaro® (2.5 mg/dose; 5 mg/dose; 7.5 mg/dose; 10 mg/dose; 12.5 mg/dose; 15 mg/dose) is a solution for subcutaneous injection in a pre-filled pen injector. One pen injector contains no less than 2.4 mL of the solution.

Only one of the following doses can be selected on each Sejaro® pen injector: 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg.

One pre-filled pen injector of each dosage contains 4 doses of Sejaro®:

• 2.5 mg/dose: 2.5 mg/0.6 mL, 10 mg of tirzepatide in 2.4 mL of the solution
• 5 mg/dose: 5 mg/0.6 mL, 20 mg of tirzepatide in 2.4 mL of the solution
• 7.5 mg/dose: 7.5 mg/0.6 mL, 30 mg of tirzepatide in 2.4 mL of the solution
• 10 mg/dose: 10 mg/0.6 mL, 40 mg of tirzepatide in 2.4 mL of the solution
• 12.5 mg/dose: 12.5 mg/0.6 mL, 50 mg of tirzepatide in 2.4 mL of the solution
• 15 mg/dose: 15 mg/0.6 mL, 60 mg of tirzepatide in 2.4 mL of the solution

Make sure to attach a new needle before each injection. After an injection, store and carry the pen injector without a needle! It helps prevent needle blocking and contamination, infection, solution leakage, and injection of a wrong dose.